Liquid chromatography (LC) coupled with mass spectrometry (MS), LC-MS, has become increasingly popular for characterizing biopharmaceutical drugs. LC-MS is widely used for characterizing the primary structure of protein drugs such as amino acid sequencing for peptides/proteins, profiling of process-related impurities such as host cell proteins (HCPs), disulfide bond mapping, N-glycan profiling of monoclonal antibodies (mAbs), and nucleotide sequencing for oligonucleotides.

At the primary structure level, the protein post-translational modifications (PTMs) that arise at different stages of manufacturing and storage can impact drug efficacy and safety; thus, PTMs are classified as critical quality attributes (CQA) that should be monitored and controlled. Combining the power of LC separation with the sensitivity and specificity of MS detection, LC-MS is the tool of choice for peptide mapping to detect multiple PTMs in a single analytical run, i.e., the multi-attribute method (MAM) workflow.

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